Faculty

Vivek Nagaraja, M.B.B.S., M.D.

Clinical Studies

A Phase 1 Study Evaluating The Safety And Preliminary Efficacy Of ALLO-329, A Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product In Autoimmune Disease (RESOLUTION) Scottsdale/Phoenix, AZ This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).
Assessing and validating the psychometric properties of the CRISTAL PRO through an online registry Scottsdale/Phoenix, AZ
The purpose of this study is to validate the CRISTAL patient-reported outcome (PRO) where patients will complete PROs at baseline and again at 6 months. The PRO includes survey items designed to assess limited cutaneous systemic sclerosis (lcSSc) symptoms and experiences from a patient perspective.

A Phase 1 Study Evaluating The Safety And Preliminary Efficacy Of ALLO-329, A Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product In Autoimmune Disease (RESOLUTION) Jacksonville, FL This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).
CAPTURE: Capillaroscopic Assessment Of Peripheral Micro-vasculature Under Research Therapies In Patients With Systemic Sclerosis Scottsdale/Phoenix, AZ
The purpose of this study is to standardize the collection of Nailfold Videocapillaroscopy (NVC) data for clinical trials and research studies involving patients with systemic sclerosis

A Multicenter, Randomized, Parallel-group, Double-blind,Two-arm Phase III Study To Evaluate The Safety And Efficacy Of Anifrolumab Compared With Placebo In Male And Female Participants 18 To 70 Years Of Age Inclusive With Systemic Sclerosis Scottsdale/Phoenix, AZ Jacksonville, FL Rochester, MN The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.